BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF SINGLEPIECE IOL

    MDR report key: 11841069 · Received May 18, 2021

    Report

    Report Number
    9612169-2021-00121
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 17, 2021
    Report Date
    September 17, 2021
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    UDI-DI
    00380650130204
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVALUATION: THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE REPORTED COMPLAINT WAS OBSERVED. PHOTO REVIEW: THE RETURNED PHOTO SHOWS IOL ON A WHITE BACKGROUND. THERE IS A LINE/MARK OBSERVED ON THE IOL OPTIC. A DEFINITIVE DETERMINATION OF DAMAGE CANNOT BE MADE WITHOUT THE EVALUATION OF THE PHYSICAL PRODUCT. ADDITIONAL OBSERVATIONS WERE AS FOLLOWS: IOL RETURNED WRAPPED IN GAUZE IN A CLEAR ZIP LOCK BAG. SOLUTION IS DRIED ON BOTH SURFACES OF THE OPTIC AND HAPTICS. BOTH HAPTICS ARE INTACT. THE OPTIC IS TORN/SPLIT-CUT, HAS LOOSE FIBERS & PARTICULATE AND HAS SCRATCHES/MARKS-REJECTABLE. ADDITIONAL INFORMATION: THE COMPLAINANT INDICATES THE USE OF A NON COMPANY PRODUCT AS A VISCOELASTIC, WHICH IS NOT QUALIFIED FOR USE WITH ASSOCIATED IOL MODEL. THE ROOT CAUSE MAY BE RELATED TO A FAILURE TO FOLLOW THE DIRECTIONS FOR USE (DFU) AS THE SURGEON STATES THE USE OF A NON-QUALIFIED VISCOELASTIC. DUE TO DIFFERING MATERIAL PROPERTIES, THE USE OF A NON-QUALIFIED VISCOELASTIC MAY RESULT IN DELIVERY ISSUES AND/OR DAMAGE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY AND BATCH RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A FACILITY REPRESENTATIVE REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT PROCEDURE, WHILE LEAVING THE CARTRIDGE AT THE TIME OF IMPLANTATION, THERE WAS A BREAK OF THE IOL. ADDITIONAL INFORMATION WAS PROVIDED THAT THE IOL BROKE DURING IMPLANTATION, AT THE PHASE OF THE IOL EXITING FROM THE CARTRIDGE NOSE. THE BREAK OCCURRED INSIDE THE EYE. A SIMILAR LENS WAS IMPLANTED A FEW MINUTES LATER THROUGH THE SAME CARTRIDGE, WITH THE SAME INJECTOR, WITH THE SAME VISCOELASTIC. THE PATIENT'S CONDITION IS SATISFACTORY. THE POSTOPERATIVE PERIOD WAS WITH NO ABNORMALITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736200 ACRYSOF SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60AT 21250789 00380650130204

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR BVI HPMC HYPROMELLOSE OPHTH SOLN USP 2% W\V| MONARCH IOL DELIVERY SYSTEM, CARTRIDGE C| MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED| BVI HPMC HYPROMELLOSE OPHTH SOLN USP 2% W\V| MONARCH IOL DELIVERY SYSTEM, CARTRIDGE C| MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED